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Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial

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Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. / Bendszus, Martin; Fiehler, Jens; Subtil, Fabien; Bonekamp, Susanne; Aamodt, Anne Hege; Fuentes, Blanca; Gizewski, Elke R; Hill, Michael D; Krajina, Antonin; Pierot, Laurent; Simonsen, Claus Z; Zeleňák, Kamil; Blauenfeldt, Rolf A; Cheng, Bastian; Denis, Angélique; Deutschmann, Hannes; Dorn, Franziska; Flottmann, Fabian; Gellißen, Susanne; Gerber, Johannes C; Goyal, Mayank; Haring, Jozef; Herweh, Christian; Hopf-Jensen, Silke; Hua, Vi Tuan; Jensen, Märit; Kastrup, Andreas; Keil, Christiane Fee; Klepanec, Andrej; Kurča, Egon; Mikkelsen, Ronni; Möhlenbruch, Markus; Müller-Hülsbeck, Stefan; Münnich, Nico; Pagano, Paolo; Papanagiotou, Panagiotis; Petzold, Gabor C; Pham, Mirko; Puetz, Volker; Raupach, Jan; Reimann, Gernot; Ringleb, Peter Arthur; Schell, Maximilian; Schlemm, Eckhard; Schönenberger, Silvia; Tennøe, Bjørn; Ulfert, Christian; Vališ, Kateřina; Vítková, Eva; Vollherbst, Dominik F; Wick, Wolfgang; Thomalla, Götz; TENSION Investigators.

in: LANCET, Jahrgang 402, Nr. 10414, 11.11.2023, S. 1753-1763.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Bendszus, M, Fiehler, J, Subtil, F, Bonekamp, S, Aamodt, AH, Fuentes, B, Gizewski, ER, Hill, MD, Krajina, A, Pierot, L, Simonsen, CZ, Zeleňák, K, Blauenfeldt, RA, Cheng, B, Denis, A, Deutschmann, H, Dorn, F, Flottmann, F, Gellißen, S, Gerber, JC, Goyal, M, Haring, J, Herweh, C, Hopf-Jensen, S, Hua, VT, Jensen, M, Kastrup, A, Keil, CF, Klepanec, A, Kurča, E, Mikkelsen, R, Möhlenbruch, M, Müller-Hülsbeck, S, Münnich, N, Pagano, P, Papanagiotou, P, Petzold, GC, Pham, M, Puetz, V, Raupach, J, Reimann, G, Ringleb, PA, Schell, M, Schlemm, E, Schönenberger, S, Tennøe, B, Ulfert, C, Vališ, K, Vítková, E, Vollherbst, DF, Wick, W, Thomalla, G & TENSION Investigators 2023, 'Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial', LANCET, Jg. 402, Nr. 10414, S. 1753-1763. https://doi.org/10.1016/S0140-6736(23)02032-9

APA

Bendszus, M., Fiehler, J., Subtil, F., Bonekamp, S., Aamodt, A. H., Fuentes, B., Gizewski, E. R., Hill, M. D., Krajina, A., Pierot, L., Simonsen, C. Z., Zeleňák, K., Blauenfeldt, R. A., Cheng, B., Denis, A., Deutschmann, H., Dorn, F., Flottmann, F., Gellißen, S., ... TENSION Investigators (2023). Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. LANCET, 402(10414), 1753-1763. https://doi.org/10.1016/S0140-6736(23)02032-9

Vancouver

Bendszus M, Fiehler J, Subtil F, Bonekamp S, Aamodt AH, Fuentes B et al. Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. LANCET. 2023 Nov 11;402(10414):1753-1763. https://doi.org/10.1016/S0140-6736(23)02032-9

Bibtex

@article{21eba215d809492ba9f903010ba27040,
title = "Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial",
abstract = "BACKGROUND: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice.METHODS: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715.FINDINGS: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone.INTERPRETATION: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection.FUNDING: EU Horizon 2020.",
author = "Martin Bendszus and Jens Fiehler and Fabien Subtil and Susanne Bonekamp and Aamodt, {Anne Hege} and Blanca Fuentes and Gizewski, {Elke R} and Hill, {Michael D} and Antonin Krajina and Laurent Pierot and Simonsen, {Claus Z} and Kamil Zele{\v n}{\'a}k and Blauenfeldt, {Rolf A} and Bastian Cheng and Ang{\'e}lique Denis and Hannes Deutschmann and Franziska Dorn and Fabian Flottmann and Susanne Gelli{\ss}en and Gerber, {Johannes C} and Mayank Goyal and Jozef Haring and Christian Herweh and Silke Hopf-Jensen and Hua, {Vi Tuan} and M{\"a}rit Jensen and Andreas Kastrup and Keil, {Christiane Fee} and Andrej Klepanec and Egon Kur{\v c}a and Ronni Mikkelsen and Markus M{\"o}hlenbruch and Stefan M{\"u}ller-H{\"u}lsbeck and Nico M{\"u}nnich and Paolo Pagano and Panagiotis Papanagiotou and Petzold, {Gabor C} and Mirko Pham and Volker Puetz and Jan Raupach and Gernot Reimann and Ringleb, {Peter Arthur} and Maximilian Schell and Eckhard Schlemm and Silvia Sch{\"o}nenberger and Bj{\o}rn Tenn{\o}e and Christian Ulfert and Kate{\v r}ina Vali{\v s} and Eva V{\'i}tkov{\'a} and Vollherbst, {Dominik F} and Wolfgang Wick and G{\"o}tz Thomalla and {TENSION Investigators}",
note = "Copyright {\textcopyright} 2023 Elsevier Ltd. All rights reserved.",
year = "2023",
month = nov,
day = "11",
doi = "10.1016/S0140-6736(23)02032-9",
language = "English",
volume = "402",
pages = "1753--1763",
journal = "LANCET",
issn = "0140-6736",
publisher = "Elsevier Limited",
number = "10414",

}

RIS

TY - JOUR

T1 - Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial

AU - Bendszus, Martin

AU - Fiehler, Jens

AU - Subtil, Fabien

AU - Bonekamp, Susanne

AU - Aamodt, Anne Hege

AU - Fuentes, Blanca

AU - Gizewski, Elke R

AU - Hill, Michael D

AU - Krajina, Antonin

AU - Pierot, Laurent

AU - Simonsen, Claus Z

AU - Zeleňák, Kamil

AU - Blauenfeldt, Rolf A

AU - Cheng, Bastian

AU - Denis, Angélique

AU - Deutschmann, Hannes

AU - Dorn, Franziska

AU - Flottmann, Fabian

AU - Gellißen, Susanne

AU - Gerber, Johannes C

AU - Goyal, Mayank

AU - Haring, Jozef

AU - Herweh, Christian

AU - Hopf-Jensen, Silke

AU - Hua, Vi Tuan

AU - Jensen, Märit

AU - Kastrup, Andreas

AU - Keil, Christiane Fee

AU - Klepanec, Andrej

AU - Kurča, Egon

AU - Mikkelsen, Ronni

AU - Möhlenbruch, Markus

AU - Müller-Hülsbeck, Stefan

AU - Münnich, Nico

AU - Pagano, Paolo

AU - Papanagiotou, Panagiotis

AU - Petzold, Gabor C

AU - Pham, Mirko

AU - Puetz, Volker

AU - Raupach, Jan

AU - Reimann, Gernot

AU - Ringleb, Peter Arthur

AU - Schell, Maximilian

AU - Schlemm, Eckhard

AU - Schönenberger, Silvia

AU - Tennøe, Bjørn

AU - Ulfert, Christian

AU - Vališ, Kateřina

AU - Vítková, Eva

AU - Vollherbst, Dominik F

AU - Wick, Wolfgang

AU - Thomalla, Götz

AU - TENSION Investigators

N1 - Copyright © 2023 Elsevier Ltd. All rights reserved.

PY - 2023/11/11

Y1 - 2023/11/11

N2 - BACKGROUND: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice.METHODS: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715.FINDINGS: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone.INTERPRETATION: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection.FUNDING: EU Horizon 2020.

AB - BACKGROUND: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice.METHODS: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715.FINDINGS: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone.INTERPRETATION: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection.FUNDING: EU Horizon 2020.

U2 - 10.1016/S0140-6736(23)02032-9

DO - 10.1016/S0140-6736(23)02032-9

M3 - SCORING: Journal article

C2 - 37837989

VL - 402

SP - 1753

EP - 1763

JO - LANCET

JF - LANCET

SN - 0140-6736

IS - 10414

ER -